NORCROSS, GA, Monday, October 16, 2017 – Patients could face increased risk of pressure ulcers due to false and misleading advertising and promotional activity by Smith & Nephew, according to new allegations in a pending lawsuit filed by Mölnlycke, a world-leading medical solutions company. The suit asserts that Smith & Nephew’s claims about the ability of its Allevyn® Life wound dressings to prevent pressure ulcers mislead healthcare decision makers into purchasing a product that lacks clinical evidence.

“Misrepresentation of facts about medical devices can expose patients to an increased risk of unnecessary pain and suffering. With a recent randomized clinical trial (RCT) demonstrating an 88 percent reduction in pressure ulcers,[1]our Mepilex® Border Sacrum has been proven effective in multiple published and peer-reviewed clinical studies, including four published RCTs.[1-8]No other 5-layer foam dressing relies on as many rigorous clinical studies,”[2,7,8] says Mölnlycke CEO, Richard Twomey. “Our proprietary Deep Defense™ technology is unique and is not replicated by any other 5-layer sacrum dressing.”[9]

The lawsuit alleges that: “Each year more than 2.5 million people in the U.S. develop pressure ulcers, resulting in 60,000 patient deaths.[10]In addition to causing unnecessary patient pain, suffering, and mortality, pressure ulcers are costly for hospitals due to longer stays, denial of payment and potential litigation. Management of pressure ulcers costs the healthcare system $11 billion annually.”[11]

The lawsuit further alleges that, “A latecomer in the area, Smith & Nephew has made false, misleading, and unsubstantiated advertising claims, including those which compare its Allevyn Life dressings to Mölnlycke’s Mepilex Border dressings.” Mölnlycke alleges that “these advertisements injure it, but more importantly, put patients at risk of unnecessary suffering and death. Mölnlycke pursues this action to stop Smith & Nephew’s false, misleading, and unsubstantiated advertising.”

The suit outlines several instances of misleading claims by Smith & Nephew through advertisements, news releases, websites, brochure and trade shows. As detailed in the filing, Smith & Nephew has:

• Claimed a 2013 publication in the International Wound Journal [12] showed its product could reduce treatment costs substantially, even though the publication was about an RCT that did not include Allevyn Life.[5] Led by Professor Nick Santamaria, a leading authority on pressure ulcer prevention, the RCT included only Mölnlycke’s Mepilex Border Sacrum and Mepilex Heel.[5]

• Asserted that a 2016 study[13]at Sidney & Lois Eskenazi Hospital in Indianapolis demonstrated its product had reduced hospital-acquired pressure ulcers (HAPUs) by 69 percent. However, the HAPU incidence rate had already declined by 60 percent before Smith & Nephew’s product was added to the study.

• Made false, misleading, and unsubstantiated claims that its products delivered greater pressure ulcer protection than Mepilex Border based on laboratory pressure redistribution studies, including one that simply positions a steel ball on a dressing that has been placed on a pressure mapping pad, despite no evidence that the tests correlate to protection in humans. Indeed, Smith & Nephew's steel ball test is criticized in published literature.[14]

The new allegations were filed in the U.S. District Court for the Northern District of Georgia. The action expands on a lawsuit originally submitted by Mölnlycke in April 2017.

[13] Swafford, K., Culpepper, R., Dunn, D, Use of a Comprehensive Program to Reduce the Incidence of Hospital-Acquired Pressure Ulcers in an Intensive Care Unit. American Journal of Critical Care, March 2016.

Mölnlycke is a provider of high-quality solutions for customers, healthcare professionals, organizations and patients worldwide. We develop and bring to market innovative wound care and surgical solutions along the entire continuum of care from prevention to post-acute settings. Our solutions provide both clinical and financial value, supported by clinical and health economic evidence. www.molnlycke.com.

About Us

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home. We specialise in solutions for managing wounds, improving surgical safety and efficiency, and preventing pressure ulcers. Our products are available in approximately 100 countries worldwide.
Mölnlycke was founded in 1849. Our headquarters are in Gothenburg, Sweden and we employ around 7,500 people. Since 2007, we belong to Investor AB, the leading owner of Nordic-based international companies.